Lundbeck delivers 14% CER revenue growth, reflecting stronger momentum from Vyepti® and Rexulti® driven by additional investments

VALBY, Denmark, Nov. 12, 2025 /PRNewswire/ -- Key highlights

Lundbeck's total revenue grew by +14% CER^[1] (+13% DKK) to DKK 18,537 million in the first nine months of 2025. Growth in the U.S. and Europe was the driver of this strong performance.

• United States: DKK 9,955 million (+22% CER; +19% DKK)
• Europe: DKK 4,318 million (+13% CER; +13% DKK)
• International Operations: DKK 3,880 million (+0% CER; -4% DKK)

The revenue of Lundbeck's strategic brands increased by +20% CER (+18% DKK), reaching DKK 14,260 million, representing 77% of total revenue

• Rexulti^®: DKK 4,695 million (+26% CER; +23% DKK)
• Brintellix^®/Trintellix^®: DKK 3,453 million (-1% CER; -3% DKK)
• Vyepti^®: DKK 3,254 million (+57% CER; +54% DKK)
• Abilify LAI franchise^[2]: DKK 2,858 million (+11% CER; +9% DKK)

EBITDA increased to DKK 6,207 million, growing +39% CER (+38% DKK) and adjusted EBITDA^[3] reached DKK 6,272 million, growing +22% CER (+21% DKK), driven by continuous strong momentum across strategic brands fueled by the strong performance of Vyepti^® and Rexulti^®. Lundbeck's disciplined capital reallocation framework allows for both investing for the future and delivering on the near-term targets, supported by a healthy cost mindset and continuous optimization of capital deployment toward the highest-return opportunities. EBITDA growth was mainly impacted by an impairment loss from one of the MAGLi projects recognized in the third quarter of 2024.

Financial guidance 2025 raised

On 11 November 2025, Lundbeck announced an increase in its full-year revenue and adjusted EBITDA guidance at CER. Revenue is now expected to grow by 13% to 14% at CER, up from the previous forecast of 11% to 13%, compared to the prior year's revenue excluding hedging effects. Adjusted EBITDA growth is now projected at 22% to 25% at CER, previously 16% to 21%, also excluding hedging effects. Further details can be found in section 2.8 Outlook.

Lundbeck's President and CEO, Charl van Zyl said:

"In the third quarter, Lundbeck continued its strong financial performance, driven by higher-than-expected growth for Vyepti^® and Rexulti^® in the U.S. The performance is a result of targeted investments enabled through our capital reallocation program. This leads us to upgrade our guidance. During the quarter, we also announced a new commercial operating model, under which 27 markets are transitioning to a partnership model. This approach frees up additional capital for reinvestment in growth opportunities, including our transformed pipeline and key commercial focus markets."

 

Recent events

On 27 October 2025, Lundbeck announced a strategic collaboration with OpenAI to transform how the company innovates and operates across its entire value chain – from molecule to patient. Through the deployment of ChatGPT Enterprise to its global workforce, Lundbeck empowers employees with AI capabilities designed to accelerate discovery, enhance decision-making, and drive unprecedented efficiency. The collaboration marks a bold step toward redefining innovation in brain health.

On 20 October 2025, Lundbeck and Contera Pharma announced a strategic research collaboration aiming to accelerate the discovery and development of innovative oligonucleotide-based medicines for patients living with serious neurological conditions, where significant unmet medical needs remain. Together, the companies will explore novel RNA-targeting treatment approaches designed to deliver transformative benefits for patients worldwide.

On 13 October 2025, Lundbeck announced that its investigational drug bexicaserin, for the treatment of seizures associated with Developmental and Epileptic Encephalopathies (DEEs), has been granted Breakthrough Therapy Designation (BTD) by China's Center for Drug Evaluation (CDE). The BTD procedure is designed to accelerate the development and review of innovative medicines for serious or life-threatening diseases with no adequate treatment options, or where early evidence shows substantial advantages over existing therapies.

On 2 October 2025, Lundbeck announced that pipeline developments regarding amlenetug, a novel investigational molecule for the potential treatment of Multiple System Atrophy (MSA), were presented at the 2025 International Congress of Parkinson's Disease and Movement Disorders^® in Honolulu, Hawaii (5-9 October). At the congress, Lundbeck shared Insights into the design of the phase III MASCOT trial and its use of innovative Bayesian progression modeling methods.

On 20 September 2025, Lundbeck and Otsuka America Pharmaceutical, Inc., (Otsuka) announced that Otsuka has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the supplemental New Drug Application (sNDA) for use of Rexulti^® (brexpiprazole) in combination with sertraline as a treatment of adults with post-traumatic stress disorder (PTSD). The CRL states that the FDA has completed their review but cannot approve the application in the current form, as the application does not provide substantial evidence of effectiveness to support the approval.

On 11 September 2025, Lundbeck announced a step forward in its commitment to advancing brain health by enhancing its leadership in migraine with a comprehensive collection of datasets presented at the 2025 International Headache Congress, which took place in São Paulo (10-13 September). Among data presented, Lundbeck announced the full results of the 12-week, open-label extension of the RESOLUTION trial investigating eptinezumab for the prevention of migraine in patients with chronic migraine and associated medication overuse headache (MOH) who also received standardized patient education.

On 9 September 2025, Lundbeck announced a change to its commercial operating model, aimed at focusing resources and capital on the highest-growth opportunities while ensuring continued patient access to our medicines. As a next step in the continued execution of its Focused Innovator strategy, Lundbeck will transition its operations to a partnership model in 27 markets in Europe and International Operations through new partnerships with Swixx Group, Zuellig Pharma, and NewBridge Pharmaceuticals. The phased transition to the partnership model is expected to be completed by December 2025 in all countries.

On 25 August 2025, Lundbeck announced that new data regarding bexicaserin, a novel treatment under investigation for seizures associated with Developmental and Epileptic Encephalopathies (DEEs), were presented at the 36^th International Epilepsy Congress (IEC) in Lisbon, Portugal (30 August – 3 September).

Strategy update – Focused Innovator

Conference call

Tomorrow at 13.00 CET, Lundbeck will be hosting a conference call for the financial community. You can find dial-ins and a link for webcast online at www.lundbeck.com under the Investor section.

Strategy update – Focused Innovator

Lundbeck progresses well on the Focused Innovator Strategy laid out in the beginning of 2024.

Scaling for the Next Phase of Growth

Lundbeck is building a stronger foundation for scale and long-term value creation. Vyepti^® and Rexulti^® provide a durable engine for reinvestment into innovation. With five to six mid to late-stage pipeline assets on track by 2026, including amlenetug and bexicaserin, and efficiency gains from the new commercial operating model, Lundbeck is structurally positioned for sustained profitability and growth driven by Rexulti^® and Vyepti^®. Building on strong cash generation and late-stage visibility, Lundbeck is well placed to deliver on its 2027 mid-term targets and extend its leadership in neuroscience well into the next decade.

Sustained growth from Strategic Brands

Lundbeck continues to demonstrate strong and consistent progress on its Focused Innovator strategy, with strategic brands delivering revenue growth of +20% CER in the first nine months of 2025 and now representing 77% of total revenue. Lundbeck's double-digit CER growth reflects the continued transformation of its commercial model toward higher-value, innovation-driven franchises. Growth was led by Vyepti^®, which continued to deliver double-digit CER growth and maintained its strong momentum across all regions. Demand remained particularly strong in the U.S., supported by total patient growth (+35%), world-class persistency (58%), and increasing dosage, overall further fueled by expanding access across Europe and International Operations. Rexulti^® sustained above 20% growth for three consecutive quarters and contributed to the strong growth in the first nine months of 2025, with targeted affordability initiatives introduced earlier in 2025 now driving stronger patient access and demand in both the Major Depressive Disorder (MDD) and agitation associated with dementia due to Alzheimer's disease (AADAD) segments. This broad-based strength underscores Lundbeck's ability to combine focused commercial execution, portfolio discipline, and operating leverage in support of sustained growth.

Pipeline Advancing Toward Late-Stage Inflection

Lundbeck advanced its late-stage pipeline during the quarter, reinforcing its commitment to deliver differentiated innovation in brain health. In migraine, Vyepti^® achieved a key regulatory milestone with FDA approval of its CHO manufacturing process and submission to the European Medicines Agency, supporting long-term supply scalability and cost efficiency. Lu AG09222 (anti-PACAP) continues to progress in phase IIb, with dose-response analyses guiding pivotal design, while a dual-active VIP-PACAP molecule has entered pre-clinical development with intended indication in cluster headache. In neuro-rare, amlenetug recruitment remains strong and remained positioned as a potential first disease-modifying therapy for Multiple System Atrophy. Bexicaserin is advancing according to plan and was granted Breakthrough Therapy Designation in China, further underscoring its global potential and the growing momentum behind Lundbeck's next wave of innovation.

Capital Efficiency Powering Innovation

Lundbeck delivered another strong operational and financial performance, demonstrating continued capital discipline and cost efficiency while investing in innovation and growth. The company achieved an adjusted EBITDA margin of 33.8% in the first nine months of 2025, supported by solid revenue growth and active cost allocation management. Strategic reallocation of resources within the Focused Innovator Strategy framework continues to fund late-stage R&D programs (adjusted R&D spending increasing 22% CER in the first nine months of 2025) and launch readiness activities without compromising profitability. Transition of 27 markets to a partnership-led model is progressing as planned and will enhance Lundbeck's flexibility and scalability across geographies. Reinvestment from these efficiencies, together with a stronger balance sheet and operating cash flow of more than DKK 4.5 billion year to date, provides Lundbeck with the capacity to advance its late-stage pipeline and support future launches. The company remains focused on maintaining a robust financial foundation while driving sustainable, innovation-led growth.

CONTENT

1 Financial highlights. 5

2 Business performance. 6

2.1 Revenue by product 6

2.2 Revenue by geographical area. 8

2.3 Gross profit 9

2.4 EBIT and adjusted EBITDA. 10

2.5 Net profit and adjusted EPS. 11

2.6 Cash flow and balance sheet 12

2.7 Summary of key developments in the third quarter of 2025. 13

2.8 Outlook. 15

2.9 Lundbeck's development portfolio. 17

2.10 Sustainability update. 18

2.11 General corporate matters. 20

3 Condensed financial statements. 23

4 Notes. 28

Financial calendar 2025. 30

¹ Change at CER (Constant Exchange Rates) does not include effects from hedging.

² Adjusted gross profit is the gross profit excluding depreciation and amortization and other adjustments linked to sales.

³ EBITDA refers to Earnings Before Interest, Taxes, Depreciation and Amortization, including impairment losses.

⁴ Adjusted EBITDA is defined as EBITDA adjusted by certain items, for details see note 4.3 Adjusted EBITDA.

⁵ Adjusted net profit is the net profit excluding depreciation and amortization and other adjustments, net of taxes.

2 BUSINESS PERFORMANCE

2.1 REVENUE BY PRODUCT

Revenue reached DKK 18,537 million representing growth of +14% CER (+13% DKK). The strong performance in strategic brands was driven by the U.S. and Europe, growing +26% CER (+23% DKK) and +18% CER (+18% DKK) , respectively. Approximately 84% of the strategic brands growth was attributable to the strong performance of Vyepti^® and Rexulti^® in the U.S. in the first nine months of 2025. Vyepti^® and Rexulti^® sales in the U.S. grew +56% CER (+53% DKK) and +26% CER (+24% DKK), respectively. The largest markets for the strategic brands was the U.S., Spain, Canada, Italy and France.

Strategic brands

The Focused Innovator Strategy amplifies Lundbeck's strategic brands representing the company's growth engine, driving revenue expansion, margin improvement, and sustainable long-term value creation.

Rexulti^® (brexpiprazole) revenue reached DKK 4,695 million representing growth of +26% CER (+23% DKK). In the U.S., revenue benefitted from continued strong demand growth^[4] in both agitation associated with dementia due to Alzheimer's disease (AADAD) and major depressive disorder (MDD). Total prescriptions (TRx) grew +23.5% year-over-year in the first nine months of 2025, reaching all-time high market share of 2.69% in August, and contributing to +21.1% growth in overall demand volume in the third quarter. In AADAD, Rexulti^® reached 4.35% market share within the Alzheimer segment and accounted for 23.4% of total U.S. Rexulti^® prescriptions in July, up from 17.8% same month of last year. In Europe and International Operations, Rexulti^® continued the strong and stable growth into the third quarter, driven by deman